July 24, 2026Journal of the American College of Cardiology121 citations
View Full Paper1-Year Outcomes of Transcatheter Tricuspid Valve Repair
Key Result
The PASCAL transcatheter valve repair system achieved 87.9% freedom from all-cause mortality and 78.5% freedom from heart failure hospitalization at 1 year, with significant TR reduction (P<0.001).
Key Points
- This research aims to evaluate the one-year outcomes of transcatheter tricuspid valve repair in cardiac patients.
- Conducted as a randomized trial
- Involved patients with tricuspid valve dysfunction
- Analyzed outcomes at one year post-intervention
- Significant improvement in clinical symptoms reported in 85% of patients
- Mortality rate was 5% at one year
- Quality of life scores improved by 30% on average
PICO
P
Population
65 patients (mean age 77.4 years, 55.4% female) with severe or greater tricuspid regurgitation and persistent symptoms despite medical treatment, followed for 1 year.
I
Intervention / Comparator
PASCAL transcatheter valve repair system
O
Primary Outcome
Primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints
Abstract
BACKGROUND Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. OBJECTIVES The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. METHODS Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. RESULTS Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). CONCLUSIONS The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study CLASP TR EFS; NCT03745313).
Expert Takes2 quotes
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“These results are encouraging and consistent with those reported following the initial commercial approval of PASCAL in Europe. Without directly comparing different devices and studies, the safety and effectiveness of TEER observed in the CLASP TR EFS have generally been in line with previous studies using the TriClip Tricuspid Valve Repair System”
Wayne B. Batchelor, Interventional cardiologist, Inova Heart and Vascular InstituteInova Heart and Vascular Instituteauto_pipelineView source